Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

97 results found

Title
Status

 

CONNECT1903 - Etude pilote et chirurgicale de larotrectinib comme traitement pour les enfants atteints d'un nouveau diagnostic de gliome de haut grade avec une fusion NTRK.

Open

CONNECT1903 - Etude pilote et chirurgicale de larotrectinib comme traitement pour les enfants atteints d'un nouveau diagnostic de gliome de haut grade avec une fusion NTRK.

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DiagnosisHigh Grade Glioma Study StatusOpen
PhaseII
AgeEnfant, Adulte - (jusqu'à 21 ans)RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationOral
Last Posted Update2024-11-05
ClinicalTrials.gov #NCT04655404
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

(Version anglophone venant du site web Australian & New Zealand Childrens Haematology/Oncology Group - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

Des recherches récentes démontrent des résultats prometteurs par rapport au nouveau médicament oral larotrectinib, celui-ci diminue la taille des tumeurs solides avec le gène NTRK anormal ou muté chez les enfants et les adultes. 

Les gliomes de haut grade (GHG) sont des cancers du cerveau agressifs qui grandissent vite, s’ils réapparaissent après un traitement initial, il n’y a aucun traitement efficace. Cette étude etudiera si le larotrectinib seul ou en combinaison avec la chimiothérapie ou la radiothérapie, pourrait aider les enfants atteint de gliome de haut grade avec le gène NTRK muté. Cet essai international étudiera la tolérance du médicament ainsi que son efficacité à diminuer la taille des tumeurs lorsqu’il est utilisé seule ou en combinaison avec un traitement standard de chimiothérapie ou après irradiation.  

Inclusion Criteria

(Version anglophone venant du site web Australian & New Zealand Childrens Haematology/Oncology Grouphttps://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

  • Age inférieur à 21 ans et nouveau diagnostic de gliome de haut grade 

  • Tumeur avec anomalie génétique nommee "NTRK fusion" 

  • Plusieurs autres critères d’inclusion et d’exclusion pourrait s’appliquer, votre équipe de traitement reverront ceux-ci avec vous 

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

Open

CONNECT1903 - A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly-Diagnosed High-Grade Glioma with NTRK Fusion

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DiagnosisHigh Grade Glioma Study StatusOpen
PhaseII
AgeChild, Adult - (up to 21 Years) RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationOral
Last Posted Update2024-10-10
ClinicalTrials.gov #NCT04655404
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
The Hospital for Sick Children - Dr. Uri Tabori
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

Recent research shows that a new oral tablet drug, larotrectinib, has produced promising results by shrinking some solid tumours that have an abnormal or mutated NTRK gene in adults and children.

High grade gliomas (HGG) are fast growing, aggressive brain cancers and if they recur after initial treatment, there are no effective treatment options. This study will investigate if larotrectinib alone as well as Larotrectinib  in combination with chemotherapy or radiotherapy can  be of benefit in children with high grade gliomas with the mutated NTRK gene. This international trial will study how well the drug is tolerated and its effectiveness to shrink these tumours when used alone or when given with standard chemotherapy or after radiation.

Inclusion Criteria

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

  • Patient must be 21 years old or younger and newly diagnosed with high grade glioma (HGG)
  • The tumour must have a genetic anomaly called an NTRK fusion for the patient to qualify
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Open

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

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DiagnosisRecurrent/Refractory Atypical Teratoid/Rhabdoid Tumor, Kidney Medullary Carcinoma, Malignant Solid Neoplasm, Poorly Differentiated ChordomaStudy StatusOpen
PhaseI/II
Age12 months of age or older RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationAtezolizumab and tiragolumab are given intravenously (IV) as infusions
Last Posted Update2024-10-04
ClinicalTrials.gov #NCT05286801
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
Patients 18+ years of age until completion of Part A.

CHU Ste Justine - Dr. Monia Marzouki
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

 

This is a phase I/II trial that studies how well the treatments tiragolumab and atezolizumab work when given to children with tumours that have either come back (relapsed) or did not respond to therapy (refractory). These tumours must have a certain mutation, meaning the cancer cells are missing important genes called SMARCB1 and SMARCA4. Tiragolumab and atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Inclusion Criteria

Part A is now completed, Part B criteria now applies: 

  • Participants must be between 1-18 years old for part A of this study. There is no upper age limit for part B
  • Participants must have one of the following cancers, that has either come back (relapsed) or did not respond to previous treatment (refractory):
    • Renal medullary carcinoma
    • Malignant rhabdoid tumor (extra-CNS)
    • Atypical teratoid rhabdoid tumor (CNS)
    • Poorly differentiated chordoma
    • Epithelioid sarcoma
  • Cancer must have the eligible mutation (SMARCB1 or SMARCA4)
  • Participants must be up and about for at least half their waking hours
  • Participants must meet all bloodwork criteria outlined for this study

Other inclusion and exclusion criteria may apply and will be discussed with you by your clinical team

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

Closed

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

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DiagnosisRetinoblastoma Study StatusClosed
PhaseI
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationTopotecan - administered using an episcleral plaque (chemoplaque), an implant which contains topotecan (drug). The implant is attached to the outside of the eye and delivers topotecan directly into the eye.
Last Posted Update2024-10-03
ClinicalTrials.gov #NCT04428879
International Sponsor
The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects and how well a chemoplaque with topotecan (a medication attached to the outside of the eye) works in treating patients with retinoblastoma. This plaque has to be installed and removed under general anesthesia by the ophthalmology team. It delivers the chemotherapy inside the eye.

Inclusion Criteria
  • Age up to 18 years
  • Retinoblastoma in at least one eye
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

JZP712-101 - A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.

Open

JZP712-101 - A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.

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DiagnosisRelapsed/Refractory Ewing SarcomaStudy StatusOpen
PhaseI/II
Age2 Years to 30 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Lurbinectedin Administered as intravenous (IV) infusion once every 3 weeks (Q3W)
Last Posted Update2024-09-26
ClinicalTrials.gov #NCT05734066
International Sponsor
Jazz Pharmaceuticals
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This study is to test the safety of a drug called lurbinectedin in solid tumours that have come back (relapsed) or not responded to treatment (refractory). It is conducted in 2 parts, Phase 2 will further assess this drug in participants with Ewing sarcoma specifically.

Inclusion Criteria
  • Participant must meet the following age requirements:
    • Phase 1 Part 1: participants must be ≥ 2 to < 18 years of age.
    • Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
    • Phase 2: participants must be ≥ 2 to ≤ 30 years of age.
  • Participant has a confirmed solid tumor (For phase 2, Ewing Sarcoma)
  • The participant is up and about for more than half their waking hours
  • Participant meets all lab value requirements during the screening period
  • Participant weighs at least 15kg
  • Must not be pregnant (if applicable), and/or must be on an acceptable birth control method 
  • Must sign informed consent and agree to attending all required study assessments 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team 

CONNECT2108 - Phase 2 Study of the MEK Inhibitor MEKTOVI® (Binimetinib) for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Open

CONNECT2108 - Phase 2 Study of the MEK Inhibitor MEKTOVI® (Binimetinib) for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

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DiagnosisAdamantinomatous CraniopharyngiomaStudy StatusOpen
PhaseII
Age1 Year to 25 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Binimetinib Oral Tablet [Mektovi]
Last Posted Update2024-09-19
ClinicalTrials.gov #NCT05286788
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr Sébastien Perreault
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

MEKTOVI (binimetinib) is a medicine taken by mouth that helps block certain signals in the body that make some tumors grow. In this Phase II study, the drug will be used to treat children diagnosed with Adamantinomatous Craniopharyngioma (ACP), a type of brain tumor. This tumor can be very challenging to treat, and current options like surgery and radiation can affect the patient's quality of life, especially when the tumor comes back.

Recent research shows that ACP might respond to medicines like binimetinib that block specific pathways in the body.

Up to 38 children will take binimetinib in pill form, twice a day for 4 weeks (1 cycle), and treatment could continue for up to two years. The trial will include children aged 1 to 25, some of whom have already had radiation therapy.

The goal is to see if this medicine can help control the tumor and improve their quality of life.

Inclusion Criteria
  • Patients must be between 1 and 25 years old.
  • Must have a confirmed Adamantinomatous Craniopharyngioma (ACP), either from a solid tumor or cyst fluid.
  • Must have a measurable tumor that can be seen on scans:
    • Stratum 1: Patients whose tumor came back or got worse at least 6 months after finishing radiation therapy.
    • Stratum 2: Patients who have had surgery but have not had radiation (they may have had other treatments before).
  • Patients must be able to do at least half of their usual activities, even if they use a wheelchair.
  • Must have recovered from any side effects of previous treatments.
  • Previous Treatments:
    • At least 7 days since the last dose of any biologic treatment (anti-tumor therapy).
    • At least 42 days since any immunotherapy (e.g. cancer vaccines).
    • At least 21 days since a monoclonal antibody treatment.
    • At least 6 months since focused radiation and no history of radiation to the whole brain/spine.
    • Corticosteroids: If on dexamethasone, the dose must be stable or reducing for at least 1 week.
    • Chemotherapy: At least 21 days since the last round of chemotherapy.
    • Surgery: At least 6 weeks since any surgery.
  • Blood counts and organ function requirements must meet certain safety levels before treatment.
  • Patient and/or their parent/guardian must agree to join the study by signing a consent form.

Additional inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

Publications

ARET2121 - Intravitreal Melphalan for Intraocular Retinoblastoma

Open

ARET2121 - Intravitreal Melphalan for Intraocular Retinoblastoma

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DiagnosisBilateral Retinoblastoma, Childhood Intraocular Retinoblastoma, Group D Retinoblastoma, Stage I Retinoblastoma, Unilateral RetinoblastomaStudy StatusOpen
PhaseII
Ageup to 18 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationCVE (Carboplatin/Vincristine/Etoposide - given intravenous (IV) Melphalan - intravitreal (injection in eye)
Last Posted Update2024-09-19
ClinicalTrials.gov #NCT05504291
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
CHU Ste. Justine - Dr. Monia Marzouki
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This trial is looking at whether adding a medicine called melphalan (which is injected into the eye) to regular chemotherapy can help treat children with retinoblastoma, a type of eye cancer. Retinoblastoma can sometimes be harder to treat when there are tiny bits of the tumor floating in the jelly-like part of the eye - called vitreous seeds. Melphalan, along with other chemotherapy drugs, works by stopping cancer cells from growing and dividing. The goal of this study is to see if adding melphalan early in treatment can better target those floating tumor bits and improve treatment for retinoblastoma.

Inclusion Criteria
  • Must be under 18 years old
  • The child must have a new diagnosis of retinoblastoma (a type of eye cancer) that is still in the eye 
  • Participant must meet one of the following conditions: 
    • Retinoblastoma in one eye (Group D) with tumor pieces floating in the eye fluid.
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye less severe (Group A-C).
    • Retinoblastoma in both eyes, with at least one eye in Group D (with tumor pieces in the fluid).
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye in Group E (most severe), where the Group E eye was removed before any treatment.
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and one Group E eye that hasn't been removed yet (depending on the doctor's decision).
  • The child must be in good enough health to handle treatment, based on performance scores for their age.
  • Blood counts and kidney function must meet certain safety levels before treatment.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

Closed

BLU-285-3101 - A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

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DiagnosisSolid Tumor, Relapsed Solid Neoplasm, CNS TumorStudy StatusClosed
PhaseI/II
Age2 Years to 17 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: avapritinib (Route: Oral) Other Name: BLU-285
Last Posted Update2024-09-18
ClinicalTrials.gov #NCT04773782
International Sponsor
Blueprint Medicines Corporation
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a phase 1/2 study that studies the drug avapritinib in patients 2-17 years old with solid tumors that have come back (relapsed) or have not responded to previous treatment (refractory). The tumor must have a certain genetic mutation (in KIT, PDGFRA or H3K27M (glioma only)) to qualify you for the study. The study consists of 2 parts; in part 1, more information will be gathered about the drug's safety and how it moves through the body (pharmacokinetics or PK) and in part 2, the effectiveness, safety and PK will continued to be monitored at the recommended dose. 

Inclusion Criteria
  • Patients must be between 2-17 years old
  • Patients must have a diagnosed solid or central nervous system (CNS) tumor that has progressed despite prior standard therapy or no alternative treatment is available 
  • Patients must be able to be up and about at least half of their waking hours (if applicable)
  • Blood work must come back within acceptable ranges within 14 days of the first study dose
  • Patients must not be pregnant on the trial, participants of child bearing potential must agree to use approved contraception methods
  • Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements